BEUDAMED
    FDA Adverse Event Other Summary report: N

    TITAN TOUCH INFLATABLE PENIS PROSTHESIS

    MDR report key: 17436435 · Received July 31, 2023

    Report

    Report Number
    MW5120414
    Event Type
    Other
    Date Received
    July 31, 2023
    Report Date
    July 14, 2023
    Manufacturer
    COLOPLAST A/S
    Product Code
    FHW
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2022, I HAD A TITAN TOUCH INFLATABLE PENIS PROSTHESIS IMPLANTED AT (B)(6) BY DOCTOR (B)(6). THE MRN: 101540, CSN: (B)(4) AND THE ENUM: 4960519 IS LISTED ON THE CARD GIVEN TO ME AFTER THE OPERATION. THE PHONE NUMBER LISTED FOR THE COLOPLAST/ TITAN TOUCH IS (B)(6). I TRIED TO USE THE PROSTHETIC AFTER BACK SURGERY IN (B)(6) ON 2023 BUT IT FAILED. ON (B)(6), 2023 I SAW DOCTOR (B)(6) IN HIS OFFICE. HE TRIED THE DEVICE AND IT WAS MAKING A SOUND HE DID NOT LIKE. A SURGERY DATE WAS SET ON (B)(6), 2023 AT (B)(6). AFTER SPEAKING WITH DOCTOR (B)(6), I CALLED THE ABOVE LISTED NUMBER AND TOLD THE COMPANY, THE PROBLEM WITH THE DEVICE. I WAS TOLD THEY WOULD SUPPLY A FREE DEVICE TO MY SURGEON AND THE ONE TAKEN OUT WOULD BE SENT BACK INTO THEM. ON (B)(6), 2023 THE SURGERY WAS PERFORMED AGAIN AT (B)(6) IN (B)(6) BY DOCTOR (B)(6). ON (B)(6), THE DAY AFTER SURGERY WE WERE BY TOLD BY DOCTOR (B)(6) TOLD THE CYLINDER HAD A HOLE IN IT. YOU MAY USE MY INFORMATION AND PLEASE LET ME KNOW IF YOU NEED ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    772446 TITAN TOUCH INFLATABLE PENIS PROSTHESIS DEVICE, IMPOTENCE, MECHANICAL/HYDRAULIC FHW COLOPLAST A/S 4960519

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown